Women across the country have brought complaints against the makers of transvaginal mesh devices like C.R. Bard’s Bard Avaulta mesh and Boston Scientific’s Pinnacle and Advantage Fit mesh, over infection injuries, erosion, vaginal scarring and other severe complications allegedly caused by the controversial products. In fact, the potential risk of injuries from vaginal mesh is severe enough that the FDA has advised doctors to consider alternatives for the repair of pelvic organ prolapse and stress urinary incontinence in women, and to inform patients about the risk of side effects from the devices. If you believe you have been harmed by complications from transvaginal mesh for the repair of pelvic organ prolapse or stress urinary incontinence, contact an experienced attorney today to explore your possible compensation options. With a knowledgeable product liability lawyer on your side, you may be able to file lawsuit against the manufacturing company, in order to seek fair and timely reimbursement for your injuries and medical bills.
Transvaginal mesh (or TVM) is a type of implantable synthetic mesh device similar to a piece of woven fabric that is commonly used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Vaginal mesh products were first introduced for hernia repair in the 1950s, and were later approved as a treatment for POP and SUI in women experiencing weakened pelvic muscles after a hysterectomy, menopause or multiple pregnancies. The net-like surgical mesh implant is typically made of a plastic substance called polypropylene, and is inserted “transvaginally,” or through the vagina, to strengthen the pelvic muscles and keep the bladder, uterus, rectum and bowel from sagging into the vaginal canal in women with POP. For SUI, the surgical mesh is used to support the urethra when pelvic muscles become weakened, and to repair ventral hernias caused in the aftermath.
Following the introduction of transvaginal mesh for POP and SUI repair, it was expected that surgical mesh would work in an overwhelming majority of cases. Instead, thousands of women across the country have suffered life-altering complications from the surgical implant, and many are now pursuing legal action against mesh manufacturing companies like Johnson & Johnson and Boston Scientific. The side effects allegedly linked to transvaginal mesh are severe and may be long-lasting, and recent research has shown that some women may be better helped by traditional methods of POP and SUI repair, which have been shown to have better benefits and fewer risks.
The very first surgical mesh device designed specifically for pelvic organ prolapse or stress urinary incontinence was manufactured by Boston Scientific and approved by the FDA in 1996, through the agency’s 510(k) premarket program. Just three years later, in 1999, the first transvaginal mesh recall was issued over safety concerns, when it was discovered that the ProtoGen Sling device “had a higher than expected rate of vaginal erosion” and did “not appear to function as intended.” Transvaginal mesh products as a whole have a checkered history, as the medical devices have been subject to numerous recalls, health advisories, and FDA-mandated warning label changes over the past two decades.
Although surgery to implant a transvaginal mesh device is easier and less invasive than traditional treatments for pelvic organ prolapse and stress urinary incontinence, the procedure also carries a higher risk of complications. In fact, in 2008, the FDA indicated that it had received more than 1,000 reports of adverse events involving surgical mesh devices to repair POP and SUI during the previous three years. Between January 2008 and December 2010, the FDA received 2,874 additional reports of complications related to vaginal mesh products, with 1,503 reports involving POP repairs, and 1,371 involving SUI repairs. The following are the most common complaints of injuries associated with TVM implantation:
In order to better evaluate the safety and effectiveness of transvaginal mesh for POP and SUI repair, the FDA conducted a review of surgical mesh studies published between 1996 and 2011, and found that “transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.” Despite these findings, the makers of transvaginal mesh devices have continued to promote their products as safe and effective products that can be used to repair weakened pelvic muscles associated with pelvic organ prolapse or stress urinary incontinence.
In most cases, vaginal mesh complications like erosion and organ perforation require revision surgery for removal and to repair any damage caused by the defective implant. However, because synthetic mesh devices were designed to remain in the body indefinitely, removal can be very difficult. Sometimes doctors must remove the mesh piece by piece, one surgery at a time.
Some of the more well-known manufacturers named in product liability lawsuits include:
The FDA paved the way for many more devices to enter the market by categorizing surgical mesh as a Class II product, which made it easier for manufacturers to gain FDA approval for new products. According to Class II guidelines, and the FDA’s 510(k) fast-track approval process, in order to get their product approved, manufacturing companies only have to show that their medical device is substantially similar to a product that is already on the market. Once it was discovered that transvaginal mesh products were prone to erosion, organ perforation and other serious injuries, the FDA issued an updated safety communication in 2012, requiring dozens of surgical mesh manufacturers to conduct post-marketing studies on the safety of their devices.
Although the FDA had previously reported in 2008, that the risk of complications from surgical mesh was rare, the agency revised its warning in a 2011 announcement, warning consumers and the medical community that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The FDA also noted that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” That same year, the FDA proposed a reclassification of surgical mesh for transvaginal POP and SUI repair from a Class II (moderate-risk) product to a Class III (high-risk) product.
According to statistics, nearly 500,000 transvaginal mesh surgeries are performed every year, and thousands of lawsuits have been filed on behalf of women across the country who have suffered serious complications and debilitating injuries allegedly caused by the controversial medical devices. To date, as many as 70,000 lawsuits brought on behalf of women injured by transvaginal mesh products are pending in the U.S. District Court for the Southern District of West Virginia, and additional claims are pending in state courts across the country.
Of the top vaginal mesh manufacturers, Boston Scientific is currently facing more than 16,000 lawsuits over injuries from its mesh products, Johnson & Johnson is facing nearly 11,000 lawsuits, and Coloplast is facing close to 2,000. By 2015, medical device maker Endo Pharmaceuticals had already paid close to $90 million to resolve lawsuits filed over injuries from surgical mesh products manufactured and sold by its American Medical Systems subsidiary.
Lawsuits brought against the makers of potentially dangerous vaginal mesh devices accuse the companies of designing and selling a defective consumer product; failing to adequately research the long-term effects of transvaginal mesh; failing to warn consumers about the risk of erosion and other injuries from vaginal mesh devices; and marketing their synthetic mesh products as safe and effective, despite information linking the mesh to serious complications, lasting injuries and permanent scarring. We are currently investigating a range of cases.
According to the FDA, it remains unclear whether transvaginal mesh is a more effective treatment option than traditional repair methods in patients with pelvic organ prolapse, a finding that has raised serious concerns among consumers, doctors and safety regulators alike. In the meantime, the agency warns that “transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.” If you or a loved one experienced complications following a transvaginal mesh procedure, we are here to help. There are legal options available for compensation in relation to pain and suffering, medical bills, loss of consortium, loss of wages and other costs associated with health issues caused by these products. Contact us today as there may be legal time limits associated with each individual TVM case. We offer free, no obligation case reviews via phone or the form on this website.